Allergy Skin Patch Artificial Intelligence (AI)
Primary Purpose
Allergic Contact Dermatitis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
AI-based smartphone application
Allergen patch
Sponsored by
About this trial
This is an interventional health services research trial for Allergic Contact Dermatitis
Eligibility Criteria
Inclusion Criteria
- Adults over the age of 18
- Willing and able to provide informed consent
Exclusion Criteria
- Under 18 years of age
- Has used topical or oral steroids two weeks prior to patch testing
- Currently taking immunosuppression agents or is immunocompromised due to medical condition
- No sunburn or rash at site of testing
- Women who are breastfeeding or pregnant.
- Treatment with ultraviolet (UV) light (including tanning) during the two weeks prior to visit.
- Subjects unable to comply with patch test study requirements including multiple return visits and activity restrictions (e.g., protecting patch test area from excess moisture due to showering)
Sites / Locations
- Mayo Clinic Florida
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Allergy Skin Patch Testing
Arm Description
On day 1, subjects will have a allergy skin patch test applied and a routine skin examination. On day 3, the patch test will be removed and documentation of the test sites using iPhone app. On day 5, the final assessment for allergic contact dermatitis will be conducted by a medical professional.
Outcomes
Primary Outcome Measures
AI algorithms predictions of reactions
Number of times the AI algorithms matches the human review of photographs of skin patch tests classification of reaction. The accuracy for the classification of regions within the test panel that either were a reaction (reaction grade 1+) or not (grade 0).
Secondary Outcome Measures
Fitzpatrick skin type assessment
Number of times the AI algorithms matches the human review of photographs of skin patch tests over the entire range of Fitzpatrick skin types. The Fitzpatrick skin typing categorize skin type according to how much melanin is present.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05339750
Brief Title
Allergy Skin Patch Artificial Intelligence (AI)
Official Title
Democratization of Allergy Skin Patch Testing to Increase Efficiency and Scale of the Practice
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
February 15, 2022 (Actual)
Primary Completion Date
September 23, 2022 (Actual)
Study Completion Date
September 23, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this research is to assess human and artificial intelligence performance in grading contact dermatitis reactions in healthy volunteers.
Detailed Description
Study participation involves three visits to the study site on Days 1, 3, and 5, and completion of a demographics and allergy history questionnaire. Researchers will review medical history and current medications. On Day 1 a patch will be applied with 10 allergens and a routine skin examination will be conducted and a photograph will be taken of the forearm. On day 3, subjects will return to remove the patch test and have photographs of the area taken. On day 5, the final assessment for allergic contact dermatitis will be performed and photographs of the area taken.
Key Information: The most common side effect of skin testing is slightly swollen, red, itchy bumps (wheals). These wheals may be most noticeable during the test. In some, an area of swelling, redness and itching may develop a few hours after the test and remain for a couple of days. Rarely, allergy skin tests can produce a severe, immediate allergic reaction. The patches are worn on the forearm for 48 hours. During this time, bathing and activities that cause heavy sweating should be avoided. Irritated skin at the patch site may indicate an allergy. If a positive test result is documented, a medical professional will provide education and recommend follow up with primary care provider.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allergic Contact Dermatitis
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
233 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Allergy Skin Patch Testing
Arm Type
Experimental
Arm Description
On day 1, subjects will have a allergy skin patch test applied and a routine skin examination. On day 3, the patch test will be removed and documentation of the test sites using iPhone app. On day 5, the final assessment for allergic contact dermatitis will be conducted by a medical professional.
Intervention Type
Device
Intervention Name(s)
AI-based smartphone application
Intervention Description
AI-based smartphone application to record and interpret the patch test results
Intervention Type
Diagnostic Test
Intervention Name(s)
Allergen patch
Intervention Description
Allergens applied to a patch which is placed on the skin on the forearm region. The patch contains 10 dime-sized disks which contain a different allergen.
Primary Outcome Measure Information:
Title
AI algorithms predictions of reactions
Description
Number of times the AI algorithms matches the human review of photographs of skin patch tests classification of reaction. The accuracy for the classification of regions within the test panel that either were a reaction (reaction grade 1+) or not (grade 0).
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Fitzpatrick skin type assessment
Description
Number of times the AI algorithms matches the human review of photographs of skin patch tests over the entire range of Fitzpatrick skin types. The Fitzpatrick skin typing categorize skin type according to how much melanin is present.
Time Frame
10 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria
Adults over the age of 18
Willing and able to provide informed consent
Exclusion Criteria
Under 18 years of age
Has used topical or oral steroids two weeks prior to patch testing
Currently taking immunosuppression agents or is immunocompromised due to medical condition
No sunburn or rash at site of testing
Women who are breastfeeding or pregnant.
Treatment with ultraviolet (UV) light (including tanning) during the two weeks prior to visit.
Subjects unable to comply with patch test study requirements including multiple return visits and activity restrictions (e.g., protecting patch test area from excess moisture due to showering)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthew Hall, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic Florida
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
12. IPD Sharing Statement
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
Learn more about this trial
Allergy Skin Patch Artificial Intelligence (AI)
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